New results in Phase III trial of Abraxane in Breast Cancer-Celgene

The German Breast Group (GBG) said Abraxane (nab-paclitaxel), from Celgene, demonstrated significant benefit for patients with early high risk Breast Cancer when compared to conventional solvent-based paclitaxel. The findings are from the GeparSepto clinical trial sponsored by GBG and conducted together with the German AGO-B study group involving over 1200 patients, which is the largest randomized Phase III study ever completed with nab-paclitaxel and the first one completed in high risk early breast cancer. The study found a statistically significant and clinically meaningful 9% absolute improvement from 29% to 38% in the pCR (pathological complete response) rate, when neoadjuvant (preoperative) chemotherapy was started with nab-paclitaxel instead of conventional solvent-based paclitaxel followed by epirubicin/cyclophosphamide given all before surgery.

Pathological complete response after neoadjuvant treatment for breast cancer is a surrogate marker for long-term efficacy. While more patients on nab-paclitaxel discontinued treatment on nab-paclitaxel compared to paclitaxel due to toxicities (17% vs 6%), the vast majority did continue onto the next stage of treatment and surgery. In addition there were fewer incidents of local disease progression (1.7% vs 5%) with nab-paclitaxel compared to solvent-based paclitaxel. Further analysis will be required to determine if toxicities in the nab-paclitaxel arm were reduced with the lower dosing. The results were presented by the coordinating investigator Michael Untch, M.D., Berlin in General Session 2 on December 10th, at the 2014 San Antonio Breast Cancer Symposium.